2013-09-16 07:18:03 -
Basilea Pharmaceutica AG /
Swissmedic accepts for review Basilea's ceftobiprole Marketing Authorization
Application for the treatment of pneumonia
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Basel, Switzerland, September 16, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the Swiss regulatory authority Swissmedic has accepted the
ceftobiprole Marketing Authorization Application for review. Ceftobiprole is an
investigational broad-spectrum anti-MRSA (methicillin-resistant Staphylococcus
aureus) antibiotic. The intended indication of ceftobiprole is for the treatment
of hospital-acquired (nosocomial) pneumonia and community-acquired pneumonia in
Ronald Scott, Chief Executive Officer of Basilea, stated: "We are very pleased
that Swissmedic will begin its review of our Marketing Authorization Application
for ceftobiprole in pneumonia. Severe pneumonia is a condition associated
morbidity and mortality which is significantly increased when MRSA is a
causative organism. Data has shown that ceftobiprole provides broad
antibacterial coverage including MRSA and Gram-negative pathogens such as
Pseudomonas. We are focused on working with Swissmedic to support their review
Basilea's submission dossier includes data from two international double-blind,
randomized, controlled phase 3 studies in hospital-acquired pneumonia and
community-acquired pneumonia. These studies compared the efficacy and safety of
empiric ceftobiprole use versus standard-of-care single or combination
Ceftobiprole in pneumonia is currently under review with European regulatory
authorities, with a decision anticipated in the second half of 2013.
Ceftobiprole is an investigational broad-spectrum intravenous antibiotic for the
potential first-line empiric treatment of severe bacterial infections.
Ceftobiprole has demonstrated broad-spectrum activity against Gram-positive
bacteria, including methicillin-resistant and vancomycin-resistant
Staphylococcus aureus (MRSA, VRSA) and penicillin-resistant Streptococcus
pneumoniae (PRSP) as well as Gram-negative pathogens, including
Enterobacteriaceae and Pseudomonas aeruginosa.
About pneumonia treated in the hospital
Community-acquired pneumonia is a common condition with up to 60% of the
patients requiring hospital admission and intravenous antibiotics. Hospital-
acquired pneumonia is one of the most common infections in the hospital,
accounting for approximately 25% of all intensive care unit (ICU) infections,
and is associated with significant mortality., Prompt empiric intervention
with an appropriate broad-spectrum antibiotic treatment is accepted as best
medical practice. The increasing incidence of bacteria resistant to many
antibiotics is a major concern.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical products in
the therapeutic areas of bacterial infections, fungal infections and oncology,
targeting the medical challenge of rising resistance and non-response to current
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition, performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different from
any future results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any forward-
looking statements contained herein as a result of new information, future
events or otherwise.
For further information, please contact:
| Media Relations | Investor Relations |
| Peer Nils Schröder, PhD | Barbara Zink, PhD, MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
This press release can be downloaded from www.basilea.com.
 Sligl WI, Marrie TJ. Severe community-acquired pneumonia. Critical Care
Clinics 2013; 29:
 Torres A, Ferrer M and Badia JR. Treatment guidelines and outcomes of
hospital-acquired and ventilator-associated pneumonia. Clinical Infectious
Diseases 2010; 51: S48-S53.
 Barbier F, Andremont A, Wolff M, Bouadma L. Hospital-acquired pneumonia and
ventilator-associated pneumonia: recent advances in epidemiology and
management. Current Opinion in Pulmonary Medicine 2013; 19: 216-228.
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